Engineer, Manufacturing Process

General Overview

Functional Area:  Engineering        
Career Stream:    Process Engineering Manufacturing    
SAP Short Name:  ENG-ENG-PRM
Job Level:  Level 07
IC/MGR: Individual Contributor        
Direct/Indirect Indicator:  Indirect    

Summary

Great oportunity to join us as Shift Engineer!

Your day-to-day activities will include the following…

• Create, execute, coordinate, and support the design of experiments, test methods, protocols, specifications, and validation documentation (IQ/OQ/PQ) and oversee the development and execution of qualification trials/characterization studies.

• Oversee and analyze the performance of equipment, vision systems and machines, optimizing process parameters to eliminate non-conforming products, low yields, or product quality issues.

• Champion and drive continuous improvement processes for production areas using structured Process Capability and Lean Six Sigma methodologies, leading cross-functional teams in these initiatives.

• Manage multiple projects, generate comprehensive project plans, and support as a team player  project teams to drive completion and success, ensuring alignment with strategic objectives.

• Support the maintenance and calibration of critical equipment-systems, ensuring compliance and optimizing maintenance schedules.

• Work with cross-functional teams and external vendors to integrate new products, processes, and technologies into the existing manufacturing area, leading the technology transfer and implementation.

Detailed Description

Performs tasks such as, but not limited to, the following:

• Design, develop, and implement new manufacturing processes to support customer products.
• Develop application software and tooling for a series of complex machines and mechanical process steps within a manufacturing sector.
• Execute with support, capability of machines and process steps using Design of Experiments and statistical methods to ensure maximum utilization of critical resources, maximum throughput, minimum cost and capacity growth; involves integrating equipment, people, material flow, and information systems.
• Solve technical product, process, component, and related problems that affect the efficient operation and/or manufacture of products.
• Provide feedback to product designers on suitability of designs for manufacturability with supervision.

This role is to work as a shift engineer, shifts are as follow:

1. A Shift: Monday, Tuesday, Wednesday and every second Sunday: 8 AM - 8 PM
2. B Shift: Sunday, Monday, Tuesday and every second Saturday night: 8 PM - 8 AM
3. C Shift: Thursday, Friday, Saturday and every second Sunday: 8 AM - 8 PM 
4. D Shift: Wednesday, Thursday, Friday and every second Saturday night: 8 PM - 8 AM

Knowledge/Skills/Competencies

What do we expect from you?

• Experience using engineering tools and software packages to support automated manufacturing processes.

• Proven experience in detailed analysis, modelling, and methodologies to validate manufacturing process and tooling design and specifications.

• Experience in creating SOP’s, Control Plans, and performing validation (FAT, SAT, IQ, OQ, PQ).

• Demonstrated ability to effectively communicate manufacturing plans, proposals, and results, and negotiate options at executive management levels.

• Experience in analytical and problem-solving skills.

• Excellent interpersonal and communication skills.

• A strong aptitude for report writing and data analytics.

• An advantage with knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485, specifically in the areas of Change Control and Validation.

What are we looking for?

• A minimum of 4+ years’ experience in a Process Engineering role, with a proven track record of involvement in projects and teams.

• A Primary Degree in an Engineering/Science discipline.

• Medical Device AND/OR Automation experience an advantage.

• Experience in a highly automated manufacturing environment.

• An ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically, and make sound decisions.

What do we ofer?

• Market-competitive total reward: flexible salary, fix and variable salary based on goals

• The opportunity to work with new product introduction teams in the Health Tech sector.

• Engineering Function driven by innovation where creativity matters.

• Training and development opportunities; with us, the sky is the limit!

• The opportunity to innovate, learn, mentor others, and work toward your own vision of career success

• A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities

• A sustainable culture where we provide opportunities for employees to give back to the community

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.